Multicenter Study Proposal: Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.

In recent years, bispecific antibodies (BsAbs) have emerged as a promising therapeutic option in hematologic malignancies, offering novel mechanisms of action by simultaneously binding two different targets. While the clinical efficacy of BsAbs has been demonstrated in several trials, their impact on the immune system, particularly in the context of infection risk, remains less well-understood. Hematologic patients are already at heightened risk of infectious complications due to immunosuppression from the disease and other therapies. However, the unique immunomodulatory effects of BsAbs may further alter the infectious risk profile in these patients, necessitating closer evaluation. Real-world data on large populations receiving these drugs is thus urgently needed to reduce morbidity and mortality from infections.

Study Design This is a prospective, multicenter, observational cohort study involving patients with hematologic malignancies who are receiving bispecific antibody therapy.

All European centers involved in hematological patients' care are invited to include their patients, on behalf of the European society of Hematology ( EHA).

Sample size A minimum of 150-200 patients to be included.

Data Collection Data will be recorded on an online platform ( www.clinicalsurveys.com) and each center will receive a code to anonymize clinical data.